Regulation

Question 1

Pure Food and Drug Act

Answer 1

1906

Truthful labeling of drugs

Question 2

Amendment to Pure Food and Drug Act

Answer 2

1912

prohibit fraudulent advertising claims

Question 3

Food, Drug, Cosmetic Act

Answer 3

1938

Require proof of drug safety and purity

Question 4

Durham-Humphrey Amendment

Answer 4

1951

FDA authority to determine which drugs can be sold w/out prescription

Question 5

Kefauver-Harris Amendment to

Food/Drug/Cosmetic Act

Answer 5

1962
proof of efficacy and safety for new drugs (and those approved since 1938)

Guidelines for adverse event reporting/ clinical testing/ advertising

Question 6

Orphan Drug Amendment

Answer 6

1983

incentive to make drugs to treat orphan diseases

Question 7

Drug Price Competition and Patent Restoration Act

Answer 7

1984
> availability of generic drugs (application easier)
longer patient life for innovative drug

Question 8

Expedited Drug Approval Act

Answer 8

1992

Accelerated FDA approval for drugs of significant medical need

Question 9

CDER

Answer 9

Center for Drug Evaluation and Research
Part of FDA

Look at Investigating New Drug
(IND) review- before start clinical trial
and
New Drug Applications - after clinical trials and now want to market

Question 10

4 Major Principles of Ethics i

in Clinical Drug Investigation

Answer 10

Trial minimizes risks for subjects

Overall care of pt

Terminate trial if risks incompatible w/ goals

Report adverse events immediately to ethics or safety committee

Question 11

Informed Consents

Patient aware of:

Answer 11

Benefits
Risks
Adverse events

no false hope
voluntary choice

Question 12

IRB

Institutional Review Board

Answer 12

Mandated and monitored by FDA
review ethical and legal issues w trial protocol
5 or > members

Question 13

IRB Members

Answer 13

1 w/ scientific expertise
1 w/ non-scientific expertise
1 w/ no institution affiliation

Question 14

IRB look at trial protocols for

5

Answer 14

Risk minimization
Risks are reasonable for benefits
Equitable selection of subjects
Informed consent process
Safeguards for vulnerable populations

Question 15

Investigational New Drug Application

Answer 15

Need to start clinical trials
have 30 days to review
-proposed trial protocol
-data from in vitro and in vivo animal studies
-biologic action of drug
-chemical properties
-drug kinetics
-plan for making drug

Question 16

Phase 1 of Clinical Trial
**
Setup

Answer 16

20-100 healthy
-unless toxicity expected
non-blinded
several months

Question 17

Phase 2 of Clinical Trial
***
Setup

Answer 17

single or double blinded
50-100s subjects
months to 2 years

Question 18

Phase 1 of Clinical Trial
**
Purpose

Answer 18

safety and identify major adverse effects
Max dose
pharmacokinetics

Question 19

Phase 2 of Clinical Trial
***
Purpose

Answer 19

Effectiveness for specific disease?
dosing, dose response
short term safety
adverse effects

Question 20

Phase 3 of Clinical Trial
***
Setup

Answer 20

Randomized, double blinded
multiple arms
multiple locations
100s-1000s # of subjects
1-4 years long

Question 21

Phase 3 of Clinical Trial
***
Purpose

Answer 21

Specific clinical/surrogate endpoints
Safety/ dosage/ effectiveness
Extrapolate results to gen pop

Question 22

New Drug Application

Answer 22

Do this after clinical trials

Asking FDA to approve for sale

Question 23

Phase 4

Answer 23

done post drug approval

may be required, not always

Question 24

In pt Prescription writing:

7

Answer 24

Pt identification
Date and time write Rx
Allergy Status
full drug name (generic)
Dose (units)
Frequency of admin
duration of therapy

Question 25

how sign in-pt prescription/order?

Answer 25

with full name title pager number

Question 26

Out-pt Prescriptions: | controlled

Answer 26

``` DEA # Class 3-5: 5 refills max or 6 month valid Class 2 no refills hard copy signature required ```

Question 27

Class 1 Controlled Drugs

Answer 27

High abuse potential no accepted medical use (Federal illegal) Examples: heroin, LSD, marijuana, MDMA, peyote, methaqualone

Question 28

Class 2 Controlled Drug

Answer 28

High abuse potential --> severe psych or physical dependence Medical use w/ severe restrictions Ex: morphine, fentanyl, methadone

Question 29

Class 3 Controlled Drugs

Answer 29

less abuse potential then 1 and 2 --> moderate to low physical dependence, high psych dependence Buprenorphine, Lortab, Tylenol 3, Dronabinol

Question 30

Class 4 Controlled Drugs

Answer 30

abuse potential low limited abuse / dependence potential Ex: Benzo, Zolpidem, Phenobarb, Darvocet

Question 31

Class 5 Controlled Drugs

Answer 31

slight abuse / dependence potential Ex: Cough syrup w/ codiene or promethazine, pregabalin

Question 32

Pregnancy Category

Answer 32

1st Trimester: > risk for sig abnormalities , major organs developing vs 3rd Trimester: more fine tuning,

Question 33

Pregnancy Category A

Answer 33

Adequate well controlled studies show no > risk in any trimester Ex: folic acid, vit B6, levothyroxine

Question 34

Pregnancy Category B

Answer 34

No evidence of harm to fetus in animal study OR Animal study has adverse effect, but pregnant women study show no risk Ex: acetaminophen, prednisone, insulin, amoxicillin

Question 35

Pregnancy Category C

Answer 35

Adverse effect in animal studies OR no animal studies conducted and no adequate human studies Ex: antidepressant, carbamazepine, cipro, fluconazole

Question 36

Pregnancy Category D

Answer 36

Adequate human studies that show a risk Therapy benefit may out-weigh risk Ex: lithium, phenytoin, valproic acid, tetracyclines, ACE-I, chemotherapy

Question 37

Pregnancy Category X

Answer 37

adequate study show high probability of risk/abnormality Contraindicated Ex: accutane, thalidomide, Cytotec